A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

NCT04662944 | Completed

• 1 other identifier: CRTH258A2402
• Study Type: observational
• Target: 494
• Locations: 5 countries
• Sites: 17

Brief Summary

RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

nAMD; Neovascular Age-Related Macular Degeneration; anti-VEGF; RAZORBILL; optical coherence tomography; OCT; Artificial Intelligence; Machine learning; Automatic OCT segmentation

Outcome Measures

Primary Outcomes (2)

• Odds ratio of disease activity assessment from Optical Coherence Tomography (OCTs) with and without enrichment

  An odds ratio of disease activity assessment from OCTs with and without enrichment was reported with a 95% confidence interval.

  12 months

• Degree of agreement in classification of disease activity using enriched and non-enriched OCT images

  Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using OCT images

  12 months

Secondary Outcomes (8)

• Difference in time needed for Disease Activity Assessment (DAA) between reviews with and without enrichment

  12 months

• Difference in confidence in DAA between reviews with and without enrichment

  12 months

• Acceptance of Discovery by physicians and whether it can optimize the ophthalmic clinical workflow

  Month 12

• Percentage of patients with absence of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment

  Month 12

• Central Subfield Thickness (CST) change

  12 months

Study Arms (1)

Licensed anti-VEGFs

Patients being treated for nAMD with licensed anti-VEGFs

Drug: brolucizumab; Drug: ranibizumab; Drug: aflibercept

Interventions

brolucizumab DRUG

There was no treatment allocation. Patients administered Brolucizumab by prescription that started before inclusion of the patient into the study were enrolled.

Licensed anti-VEGFs

ranibizumab DRUG

There was no treatment allocation. Patients administered Ranibizumab by prescription that started before inclusion of the patient into the study were enrolled.

Licensed anti-VEGFs

aflibercept DRUG

There was no treatment allocation. Patients administered Aflibercept by prescription that started before inclusion of the patient into the study were enrolled.

Licensed anti-VEGFs

Eligibility Criteria

• Age: 18 Years - 199 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.

You may qualify if:

• Diagnosis of nAMD
• Male and Female patients with ≥18 years of age at index
• Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period
• Signed written informed consent
• Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label
• Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening

You may not qualify if:

• Patients treated for any other retinal disease than nAMD within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic CNV, and have diagnoses of diabetes-related macular degeneration)
• Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at screening
• Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
• Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
• Patients who have any contraindication and are not eligible for treatment with the chosen anti-VEGF treatment as according to the respective label.
• Any medical or psychological condition, in the treating physician's opinion, which may hinder the patient from participating in this study for the expected 12 months
• Patients participating, in parallel, in an interventional clinical trial
• Patients participating, in parallel, in any other Novartis sponsored NIS generating primary data for an anti-VEGF drug

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Hamilton, Ontario, L8G 5E4, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M8X 2X3, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H1V 1G5, Canada

Location

Novartis Investigative Site

Ludwigsburg, Baden-Wurttemberg, 71638, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Düsseldorf, 40212, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Ulm, 89075, Germany

Location

Novartis Investigative Site

Glasnevin, Dublin 9, D09 YN97, Ireland

Location

Novartis Investigative Site

Waterford, 48327, Ireland

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Milan, MI, 20157, Italy

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Bormujos, Sevilla, 41930, Spain

Location

Novartis Investigative Site

León, 24080, Spain

Location

Related Links

• Results for CRTH258A2402 that is getting linked from the Novartis Clinical Trials Website

MeSH Terms

Interventions

brolucizumab; Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 10, 2020
• Study Start: February 23, 2021
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2); IT (2); DE (6); ES (4); CA (3)